Regulatory services, documents and data management

Data Management & Standardisation

 

Withe increase in the number of core activity databases, the need for these databases to be interconnected and the constraints relating to auditability, data must be managed in a way that is detailed, updated and standardised. Within R&D organisations, meeting these constraints internally is often difficult as resources are mainly focused on development projects as opposed to data maintenance.

 

Client objectives

  • Save time and reduce costs
  • Improve efficiencies and quality
  • Guarantee the quality of the data managed
  • Compliance with ISO standards (Europe) or CMM standards (US)

 

ProductLife's services can cover a number of core R&D activities:

  • Regulatory (regulatory tracking of multi-country submissions)
  • Clinical fields (clinical trial management)
  • Non-clinical fields (toxicology for example)
  • CMC/Quality
  • Quality assurance (SOP management, corrective actions and preventative actions)

 

Expertise and consultancy services

The Consulting division of ProductLife has worked on the analysis stages of PLM (Product Lifecycle Management) and/or MDM (Master Data Management) projetcs and has also been involved in the standardisation of data and the definition of system interface guidelines.

 

Operational support

The objective of these services is to ensure that core activity data, whether in the form of digital archives, databases or electronic documents, is kept up-to-data, accurate, accessible and available for auditing at any stage. These services relate to the following areas:

  • Administration (non-IT) of databases for core activities
  • Data capture (input of form data or bulk scanning)
  • Data management and data Quality (use of dictionaries, definition of consistency criteria)
  • Preparation of data for physical and electronic archiving
  • Bibliographic research.

Latest News

Wednesday 20.06.2012
Kostenloses Business Frühstück in München: „Regulatory Information Management System“ (RIMS)
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Wednesday 06.06.2012
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